Distribution and Analysis of Metastatic Lymph Nodes in Colorectal Cancer Patients (DIAMOND)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Colon Cancer, Rectal Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to learn about the spatial distribution and significance of metastatic lymph nodes in colorectal cancer patients. The main question it aims to answer is: * What is the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer? * Can the spatial distribution pattern of metastatic lymph nodes in patients with colorectal cancer guide clinical practice? Participants should undergo regular follow-up examinations for at least 5 years after the surgery.
Primary outcome measures
- The spatial distribution of metastatic lymph nodes [Time frame: From enrollment to 14 days after surgery (at the completion of postoperative pathological examination)]
Secondary outcome measures (2)
- Disease-free survival [Time frame: From date of surgery until the date of first documented local recurrence, distant metastasis, or date of death from any cause, whichever came first, assessed up to 60 months]
- Overall survival [Time frame: From date of surgery until the date of death from any cause, whichever came first, assessed up to 60 months]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 80 years
- Pathologically confirmed adenocarcinoma of the colon or rectum
- Underwent radical resection for colorectal cancer with a D3 lymphadenectomy and lymph nodes were submitted for pathological examination according to standardized station-based and distance-based protocol
- No distant metastasis or distant metastasis within 6 months after surgery
- No history of other malignant tumors or severe systemic diseases
- No immune diseases or inflammatory bowel diseases
- Non-emergency surgery
- With complete clinicopathological and follow-up data
Exclusion criteria
- Pathologically confirmed benign tumors or non-adenocarcinoma malignancies
- Underwent local excision or palliative resection
- Regional lymph nodes were not dissected or submitted for pathological examination according to the unified station-based or distance-based protocol
- With distant metastasis or distant metastasis within 6 months after surgery
- Dual or multiple primary colorectal cancers or concurrent other malignant tumors
- Had a previous diagnosis of immune diseases or inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Underwent emergency surgery
- Had incomplete clinicopathological or follow-up data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07306390 · 25/631-5577